Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction
Primary Purpose
Heart Failure With Preserved Ejection Fraction
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization
Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure With Preserved Ejection Fraction
Eligibility Criteria
Inclusion Criteria:
- Patients presenting with symptoms and signs suggestive of HFpEF
- Patients undergoing coronary catheterisation for stable chest pain with no evidence of diastolic dysfunction, heart failure, infarct, left ventricular ejection fraction <50% or significant coronary artery disease (ie. >50% narrowing of one or more coronary arteries)
- Volunteers must be asymptomatic with no cardiac risk factors and no previous cardiac history
Exclusion Criteria:
- Patients suspected to have HFpEF but echocardiography and/or invasive pressure measurements do not confirm diagnosis of HFpEF.
- Significant underlying ischaemia based on clinical history and non-invasive imaging or catheter coronary angiography if indicated.
- Contraindication to CMR study
- Estimated glomerular filtration rate <30 ml/min/1.73 m2
- More than moderate valvular disease
- Severe pulmonary disease (ie. FEV1 <- 50% predicted)
- Cardiomyopathy
- Constrictive pericarditis
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Patients with heart failure with preserved ejection fraction
Non-heart failure patients
Normal Volunteers
Arm Description
Outcomes
Primary Outcome Measures
Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers
Secondary Outcome Measures
Complication rate of cardiac catheterisation
Unexpected findings by CMR (eg. Cardiac amyloidosis)
Full Information
NCT ID
NCT04063579
First Posted
August 16, 2019
Last Updated
May 8, 2023
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04063579
Brief Title
Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction
Official Title
Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 29, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective study that aims to define the utility of cardiac magnetic resonance feature tracking (CMR-FT) as a non-invasive quantification tool to assess diastolic functionality in patients with Heart Failure with preserved ejection fraction.
Detailed Description
Despite the increasing prevalence and poor prognosis of HFpEF worldwide, it is facing diagnostic challenges due to its non-specific clinical manifestations. Currently, echocardiography serves as the main diagnostic tool, but alternatives are limited to less preferred invasive procedures in most clinical situations.
It is therefore proposed to investigate HFpEF using cardiovascular magnetic resonance imaging (CMR), as an alternative non-invasive diagnostic tool which carries lower risk than invasive procedures.
The study aims to: (1) access the utility of CMR-FT as a new indicator to diagnose diastolic dysfunction by differentiating HFpEF patients from non-HFpEF patient and normal volunteers. (2) Compare accuracy of CMR-FT to CMR tagging and phase contrast imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with heart failure with preserved ejection fraction
Arm Type
Experimental
Arm Title
Non-heart failure patients
Arm Type
Experimental
Arm Title
Normal Volunteers
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization
Intervention Description
Imaging, blood tests, LV pressure measurement
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)
Intervention Description
Imaging and Blood tests
Primary Outcome Measure Information:
Title
Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Complication rate of cardiac catheterisation
Time Frame
2 years
Title
Unexpected findings by CMR (eg. Cardiac amyloidosis)
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients presenting with symptoms and signs suggestive of HFpEF
Patients undergoing coronary catheterisation for stable chest pain with no evidence of diastolic dysfunction, heart failure, infarct, left ventricular ejection fraction <50% or significant coronary artery disease (ie. >50% narrowing of one or more coronary arteries)
Volunteers must be asymptomatic with no cardiac risk factors and no previous cardiac history
Exclusion Criteria:
Patients suspected to have HFpEF but echocardiography and/or invasive pressure measurements do not confirm diagnosis of HFpEF.
Significant underlying ischaemia based on clinical history and non-invasive imaging or catheter coronary angiography if indicated.
Contraindication to CMR study
Estimated glomerular filtration rate <30 ml/min/1.73 m2
More than moderate valvular disease
Severe pulmonary disease (ie. FEV1 <- 50% predicted)
Cardiomyopathy
Constrictive pericarditis
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
36992915
Citation
Ng MY, Kwan CT, Yap PM, Fung SY, Tang HS, Tse WWV, Kwan CNF, Chow YHP, Yiu NC, Lee YP, Fong AHT, Hwang S, Fong ZFW, Ren QW, Wu MZ, Wan EYF, Lee KCK, Leung CY, Li A, Montero D, Vardhanabhuti V, Hai J, Siu CW, Tse HF, Pennell DJ, Mohiaddin R, Senior R, Yiu KH. Diagnostic accuracy of cardiovascular magnetic resonance strain analysis and atrial size to identify heart failure with preserved ejection fraction. Eur Heart J Open. 2023 Mar 7;3(2):oead021. doi: 10.1093/ehjopen/oead021. eCollection 2023 Mar.
Results Reference
result
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Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction
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